Sr Supplier Engineer

Intuitive•Sunnyvale, CA

9d•$136,500 - $231,000•Onsite

About The Position

The Sr Supplier Engineer ensures high quality and stable delivery of purchased production components from suppliers operating under robust quality systems. The role is responsible for ensuring suppliers meet Intuitive Surgical requirements for product quality, cost, and service. It supports part qualification, manufacturing process selection and development, supplier change management, supplier selection and evaluation, and supplier relationship development. The position works across internal teams and suppliers to establish capable processes, address technical and quality issues, and maintain supply-chain readiness.

Requirements

Bachelor’s degree in an engineering field.
At least 8 years of related experience in manufacturing, supplier process engineering, design, or a related field.
Excellent written and verbal communication skills.
Experience creating and aggregating DFM feedback.
Demonstrable knowledge of evaluating and challenging suppliers’ technical, quality, and business capabilities.
Experience with a wide range of manufacturing processes, including understanding key input variables for quality, cost, and capacity.
Proven ability to motivate suppliers and lead teams in solving difficult technical and process problems.
Knowledge of pFMEA, process validation, inspection, and test techniques.
Familiarity with 21 CFR Part 820 and ISO 13485.
At a minimum, understanding of GDP and QMS methods.
Significant computer experience using Windows, Word, Excel, Access, and ERP information systems.
Ability to read and interpret detailed specifications and schematics and communicate technical information.
Ability to travel to suppliers as needed, domestically and internationally.

Nice To Haves

Experience auditing suppliers to 21 CFR Part 820 and ISO 13485 standards.
Experience using SAP.
Experience in a medical device company.
Experience with low-volume, high-mix production environments.
Product experience with machining, including 4- and 5-axis holdings, FMS, and bar-fed lathes; plastic injection molding or other plastic forming processes; die casting; or Thixomolding.

Responsibilities

Support Value Engineering and Quality Improvement Part Qualification efforts.
Lead Core Product Teams in defining appropriate part qualification requirements, including testing and inspection requirements before system integration.
Support transfer of parts between suppliers.
Complete Production Part Qualification Process deliverables, including Supplier pFMEA, Special Process Validations, FAI, and Process Capability Analysis.
Perform product and process risk analysis and ensure mitigations are implemented and effective before product introduction.
Establish sustainable process capability at suppliers and critical sub-tier suppliers.
Support manufacturing line escalations from manufacturing teams.
Drive corrective actions using root cause tools such as 8D and 5 Why, determining root causes and implementing effective corrective and preventive actions.
Lead manufacturing process selection, considering process quality, long-term capacity, and total lifecycle cost.
Identify opportunities for Design for Manufacturing (DFM) to improve quality, reduce costs, or increase supply-chain capacity.
Educate internal customers and suppliers about supplier quality, process and operational capabilities, and best-value manufacturing methods and tooling for key supplier processes.
Drive improvements to Intuitive requirements by proposing and managing specification and drawing changes through the ECO process.
Manage planning and implementation of supplier change management projects using the Supplier Change Request process after Design V&V.
Provide status on supply-chain readiness, including quality, capacity, and delivery, for major production process changes.
Work cross-functionally to improve supplier engineering processes.
Support supplier selection by working with Product Design, Commodity Managers, and other stakeholders to identify capable suppliers for new products based on business need and supplier capability.
Evaluate new suppliers through informal assessments and formal assessments, supporting lead auditors in QMS evaluations.
Support audit teams in addressing findings and developing suppliers’ quality and business systems to meet Intuitive requirements.
Manage supplier relationships to establish effective partnerships.